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. Author manuscript; available in PMC: 2018 Apr 11.
Published in final edited form as: N Engl J Med. 2017 Jan 12;376(2):125–135. doi: 10.1056/NEJMoa1607427

Table 3. Overview of Adverse Events (Safety Population)*.

Event 177Lu-Dotatate Group (N = 111) Control Group (N = 110) P Value
number of patients (percent)

Adverse event

 Any 106 (95) 95 (86) 0.02
 Related to treatment 95 (86) 34 (31) <0.001

Serious adverse event

 Any 29 (26) 26 (24) 0.76
 Related to treatment 10 (9) 1 (1) 0.01

Withdrawal from trial because of adverse event

 Because of any adverse event 7 (6) 10 (9) 0.46
 Because of adverse event related to treatment 5 (5) 0 0.06
*

The safety population included all patients who underwent randomization and received at least one dose of trial treatment.

P values were calculated with the use of Fisher's exact text.